The study aimed to assess the intrauterine ball IUB Ballerine MIDI copper IUD’s acceptability, using real-world data collected from users and physicians in Israel.
In this retrospective, observational study, conducted in a single clinic in Israel,175 healthy women who had had the device inserted ≥12 months before enrolment, and their physician, completed questionnaires relating to device insertion, user experience, and performance.
The mean age at insertion was 32.8 ± 6.7 years; most women were married and multigravid. At the time of the study, 131 women were still using the device; in 13 cases, premature removal was due to the desire to conceive. The expulsion rate was 3.4%, and the pregnancy rate was 0.57%. Most of the women still using the device reported no to moderate pain or cramps and moderate to high satisfaction with the machine; 76.3% said they would recommend it to friends and relatives. Most of the insertion procedures were uneventful, and none required cervical dilation.
The study concluded that IUB Ballerine MIDI raised no major safety concerns and was both useful and highly accepted in a cohort of women, covering a broad age range, treated in a gynecology clinic in Israel.